LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide lotion

La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen by

Drug Labeling and Warnings

La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 Sunscreen by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, Cosmetique Active Production, Interspray, Goodier Cosmetics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Titanium dioxide 11%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  

Warnings

For external use only

Do not use

on damaged or broken skin

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if 

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

- shake well before use

- apply generously 15 minutes before sun exposure

- reapply:

- after 40 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection meausures including:

- limit time in the sun, especially from 10 a.m. - 2 p.m.

- wear long-sleeved shirts, pants, hats and sunglasses

- children under 6 months of age: Ask a doctor

Other information

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

water, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, PEG-9 polydimethylsiloxyethyl dimethcone, iron oxides, alumina, polyhydroxystearic acid, phenoxyethanol, magnesium sulfate, propylene glycol, caprylyl glycol, aluminum hydroxide, PEG-8 laurate, stearic acid, disteardimonium hectorite, diethylhexyl syringlidenemalonate, tocopherol, propylene carbonate, cassia alata leaf extract, maltodextrin, benzoic acid, disodium stearoyl glutamate, PEG-9

Questions or comments?

1-888-577-5226   1-888-LRP LABO

Monday - Friday (9 a.m. - 5 p.m. EST)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE ANTHELIOS 50 TINTED MINERAL FACE BROAD SPECTRUM SPF 50 SUNSCREEN 
titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	110 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ISODODECANE (UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
UNDECANE (UNII: JV0QT00NUE)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
ISOHEXADECANE (UNII: 918X1OUF1E)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
NYLON-12 (UNII: 446U8J075B)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
PHENETHYL BENZOATE (UNII: 0C143929GK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TRIDECANE (UNII: A3LZF0L939)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
TALC (UNII: 7SEV7J4R1U)
ALUMINUM STEARATE (UNII: U6XF9NP8HM)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
FERRIC OXIDE RED (UNII: 1K09F3G675)
ALUMINUM OXIDE (UNII: LMI26O6933)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
PEG-8 LAURATE (UNII: 762O8IWA10)
STEARIC ACID (UNII: 4ELV7Z65AP)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
TOCOPHEROL (UNII: R0ZB2556P8)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SENNA ALATA LEAF (UNII: 4BXR6YZN92)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DISODIUM STEAROYL GLUTAMATE (UNII: 45ASM2L11M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-020-01	1 in 1 CARTON	01/30/2017
1		50 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 49967-020-02	1 in 1 CARTON	01/30/2017
2		3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 49967-020-03	1 in 1 CARTON	01/30/2017
3		125 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/30/2017

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmetique Active Production		282658798	manufacture(49967-020) , analysis(49967-020)

Establishment
Name	Address	ID/FEI	Business Operations
Interspray		364829903	pack(49967-020)